Getinge Flow-c Anesthesia System Software Bug May Prevent Ventilation
The Getinge Flow-c Anesthesia System contains a software bug that can prevent pressure buildup and ventilation delivery. Under certain conditions, oxygen delivery may decrease, which may lead to hypoventilation and hypoxia.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: FDA Class I classification requires a minimum severity score of 4. The software bug can prevent ventilation and oxygen delivery in an anesthesia system, creating serious patient safety risk. No deaths or hospitalizations are reported in the source material.
Plain-English summary
Getinge is recalling the Flow-c Anesthesia System (Part No. 6887700) due to a software bug in versions 4.8.0, 4.8.1, 4.8.2, and 4.8.3. The bug prevents pressure from building up under certain conditions, which can result in no ventilation delivery. If gas delivery is stopped, a sustained decrease in delivered oxygen concentration may lead to hypoventilation and hypoxia.
8,016 units have been distributed worldwide, including 250 units within the United States across multiple states (AL, AR, AZ, CA, CO, DC, FL, GA, IN, MA, MI, MO, NY, OH, OR, PA, TX, VA, WA, WV). Affected serial numbers range from 4003 to 5078.
The recalled product
- Product
- Getinge Flow-c Anesthesia System, Part No. 6887700
- Manufacturer
- Getinge Usa Sales Inc
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- 4.8.1
- 4.8.2
- and 4.8.3.
Distribution
Part of a larger recall action
This product is one of 3 recalled by Getinge Usa Sales Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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